Direct answer: flexible-packaging buyers should request a compliance package tied to the exact material structure and intended use. A generic “food grade,” “FDA approved” or supplier certificate is not enough to establish suitability for every food, temperature, contact time or market.
The documentation must identify the food-contact layer, other relevant layers and substances, regulatory basis, use limitations, test conditions and the revision or lot covered. Responsibility also extends to printing, lamination, curing, converting, filling and the completed package.
Define intended use before requesting documents #
In the United States, FDA food-contact status depends on the substance, authorization and conditions of use. FDA explains that a Food Contact Notification is effective for the identified manufacturer or supplier and the intended use described in the notification. Other regulatory routes may include applicable provisions in Title 21 of the Code of Federal Regulations or another valid basis.
In the European Union, Regulation (EC) No 1935/2004 provides the general framework for materials intended to contact food. Commission Regulation (EU) No 10/2011 provides specific rules for plastic materials and articles and includes requirements for a written declaration of compliance at applicable supply-chain stages.
Before asking a supplier for evidence, state:
- target market or markets;
- food type, including whether it is aqueous, acidic, alcoholic, fatty or dry;
- direct or indirect contact and which surface faces the food;
- contact time and temperature across filling, processing, storage and use;
- hot fill, microwave, frozen, retort or other special conditions;
- whether the package is single-use or repeatedly opened;
- complete laminate, ink, adhesive, coating and closure construction.
The flexible-packaging material structure FAQ helps buyers define the layers and their functions before compliance evidence is collected.
Core documents to request #
| Document or record | What it should identify | Buyer check |
|---|---|---|
| Statement or declaration of compliance | Supplier, material identity, regulatory basis, restrictions, intended conditions and issue date. | Does it cover the exact grade and structure being purchased? |
| Full structure declaration | Face film, barrier, tie or adhesive layers, sealant, coating, ink position and any relevant closures. | Is the food-contact surface unambiguous, and are revisions controlled? |
| Supporting substance or formulation information | Applicable resin, additive, adhesive, coating and ink compliance basis without requiring disclosure of protected formulas beyond what law and qualification require. | Are use limitations and relevant restricted substances identified? |
| Migration or extractables test report | Sample identity, laboratory, method, simulant or food, time, temperature, surface-area relationship, analytes and results. | Do the conditions represent the intended use and current package? |
| Good manufacturing and change-control evidence | Traceability, controlled specifications, curing or set-off controls where relevant, nonconformance handling and notification of changes. | Will a material, ink, adhesive or process change trigger review? |
| Finished-package validation records | Evidence that printing, lamination, converting and filling do not invalidate the selected compliance basis. | Who owns final review and market-release responsibility? |
Read migration reports against the actual application #
A test report is not transferable merely because the film name looks similar. Check the sample code, total structure, food-contact side, test date, laboratory, method, simulant or food, time, temperature and analytical scope. Confirm whether the report addresses overall migration, specific substances, non-intentionally added substances where relevant, or only a narrow screen.
Do not assume that the most severe-looking condition is scientifically appropriate for every application. The compliance team should select conditions that correspond to the applicable regulatory framework and foreseeable use.
Printing and lamination remain part of the assessment #
Ink printed on the outside is not automatically outside the risk assessment. Set-off in a wound roll or stack, diffusion through layers, incomplete curing, residual solvents and transfer at seams may need consideration depending on the construction and process. Adhesives and coatings likewise require an applicable compliance basis and adequate process control.
Commission Regulation (EC) No 2023/2006 requires good manufacturing practice for materials and articles intended to contact food. Documentation should therefore cover not only raw-material declarations but also the controlled production route.
The published Soy-Based Ink vs Conventional Ink FAQ explains why an ink label or sustainability claim does not automatically establish food-contact suitability for the completed package.
FDA, EU and customer requirements are not interchangeable #
A statement supporting a U.S. use does not automatically satisfy EU declaration and migration requirements, and an EU declaration does not automatically establish compliance in every other market. Customer restricted-substance lists, retailer protocols and product-specific rules may add further requirements.
Use the target market and intended-use matrix to request the correct evidence. If a supplier cites a regulation, ask for the exact section, authorization, restriction or notification that supports the material and condition of use.
Chinese supply-chain terminology to clarify #
In Chinese packaging procurement, buyers may encounter terms such as “food grade,” “FDA material,” “EU test,” or a general laboratory certificate. These descriptions are not a universal Chinese compliance format. Ask which material grade and supplier are covered, which regulation or authorization is cited, whether the full laminate or only one resin was tested, and whether the intended food and temperature conditions match the order.
UGI Packging recommends attaching the approved compliance matrix to the RFQ and purchase specification. The custom flexible-pouch RFQ checklist identifies the application inputs, and the sample validation FAQ explains why the final structure and production-representative sample must be confirmed before mass production.
Buyer review sequence #
- Define market, food, contact surface, time, temperature and processing.
- Freeze the full package structure and supplier grades.
- Map each component to its regulatory or authorization basis.
- Review declarations and test reports for exact scope and limitations.
- Assess printing, adhesive, curing, set-off and converting controls.
- Confirm finished-package responsibilities with the filler and brand owner.
- Establish change notification, traceability and requalification rules.
Frequently asked questions #
Is an “FDA approved” certificate enough for a flexible pouch? #
No. Ask for the exact regulatory basis, material or substance identity, supplier, intended food-contact conditions and any limitations. The completed structure and actual use must match the supporting evidence.
Does a declaration for the inner sealant cover the whole laminate? #
Not automatically. The sealant declaration is important, but adhesives, inks, coatings, other layers, set-off and converting conditions may also require assessment for the completed package.
Can one migration report be used for every food and temperature? #
No. Review the sample, simulant or food, contact time, temperature, surface-area relationship and analytical scope. The report must be relevant to the intended application and target regulation.
What should happen when a supplier changes an ink, adhesive or film grade? #
The change should trigger written notification and a documented risk review. The parties should determine whether updated declarations, testing or finished-package revalidation are required before the changed material is accepted.
Official regulatory references #
- U.S. FDA: Food Contact Substances
- Electronic Code of Federal Regulations: 21 CFR Part 174
- EU Regulation (EC) No 1935/2004 on food-contact materials and articles
- Consolidated Commission Regulation (EU) No 10/2011 on plastic food-contact materials
- Commission Regulation (EC) No 2023/2006 on good manufacturing practice
